Telehealth Program in Chronic Patients

NCT02269618 | Completed

• 1 other identifier: N.160
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Keywords

Telehealth, Home-based, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Improvement tolerance capacity

  The improvement in tolerance capacity will be measured by walking test performance (meters walked)

  4 months and 6 months

Secondary Outcomes (7)

• Reduction of hospitalisations for cardiovascular disease and /or respiratory disease

  4 months

• Reduction of hospitalisations for all-cases

  4 months

• energy expenditure and duration and quantification of physical activity Energy expenditure and duration and quantification of physical activity

  4 months and 6 months

• Improvement of quality of life

  4 months

• Reduction of clinical instabilities without hospital admission

  4 months

Study Arms (2)

Control group (Group A)

ACTIVE COMPARATOR

The patients will be followed in the usual care manner by GPs and by routine specialist visits, if needed

Other: Usual care

Intervention group (Group B)

OTHER

Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be: 1. Home-based telehealth program 2. Home-based rehabilitation

Other: Home-based telehealth program; Other: Home-based rehabilitation; Other: Usual care

Interventions

Home-based telehealth program OTHER

Home-based telehealth program * Scheduled calls initiated by nurse performed weekly; the nurse carried out a standardized interview on general clinical condition of the patients. * Unscheduled calls initiated by patients or caregivers through the service centre(24h/24h) to report any clinical problems. in case of signs or symptoms * Telemonitoring: during calls, patients can transmit via landline or mobile phone the recordings from the 1-lead ECG to a service centre, and talk to the nurse or doctor * Home visit performed by therapist seven days after hospital discharge by setting the daily physical activity and other home visits in case of need * Scheduled calls initiated by therapist performed weekly aimed at increasing workload and evaluating the proper execution of exercises.

Intervention group (Group B)

Home-based rehabilitation OTHER

Home-based rehabilitation Individual rehabilitative program including at least 3 sessions/week of mini-ergometer and exercises and 2 sessions/week of walking with pedometer * Mini-ergometer: The personalized protocol will be structured at the beginning on the basis of data obtained from the assessment of the baseline exercise test, trying to get a training activity to the maximum value of around a Borg dyspnoea and motor equal to 6 (according to the protocol of Maltais) * Walking: The patient will be encouraged to walk every day. Will be given a pedometer and will be asked to try to increase the amount of steps up to the maximal for the patient.

Intervention group (Group B)

Usual care OTHER

Usual care All patients will be followed also in usual care manner by their GPs.

Control group (Group A); Intervention group (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD new GOLD classification (B, C and D class) and a spirometry in the previous year and
• Systolic and/or diastolic CHF defined at least by an echocardiogram performed in clinical stability; II, III and IV New York Heart Association class and optimized drug therapy.
• Informed consent signed

You may not qualify if:

• Physical activity limitations caused by non-cardiac and/or pulmonary problems
• Obstructive Cardiomyopathies and/or myocarditis
• Non cardiac and/or pulmonary pathologies that would cause the death of the patient during the study
• Poor adherence and compliance of the patient

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (3)

FSM Respiratory Unit

Lumezzane, BS, 25066, Italy

Location

Fondazione Salvatore Maugeri, Cardiology Unit

Lumezzane, BS, Italy

Location

Fondazione Salvatore Maugeri, Telemedicine Service

Lumezzane, BS, Italy

Location

Related Publications (12)

• Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013.

  PMID: 19168510 BACKGROUND

• Staszewsky L, Wong M, Masson S, Barlera S, Carretta E, Maggioni AP, Anand IS, Cohn JN, Tognoni G, Latini R; Valsartan Heart Failure Trial Investigators. Clinical, neurohormonal, and inflammatory markers and overall prognostic role of chronic obstructive pulmonary disease in patients with heart failure: data from the Val-HeFT heart failure trial. J Card Fail. 2007 Dec;13(10):797-804. doi: 10.1016/j.cardfail.2007.07.012.

  PMID: 18068611 BACKGROUND

• Macchia A, Monte S, Romero M, D'Ettorre A, Tognoni G. The prognostic influence of chronic obstructive pulmonary disease in patients hospitalised for chronic heart failure. Eur J Heart Fail. 2007 Sep;9(9):942-8. doi: 10.1016/j.ejheart.2007.06.004. Epub 2007 Jul 12.

  PMID: 17627878 BACKGROUND

• Almagro P, Castro A. Helping COPD patients change health behavior in order to improve their quality of life. Int J Chron Obstruct Pulmon Dis. 2013;8:335-45. doi: 10.2147/COPD.S34211. Epub 2013 Jul 24.

  PMID: 23901267 BACKGROUND

• Walters JA, Cameron-Tucker H, Courtney-Pratt H, Nelson M, Robinson A, Scott J, Turner P, Walters EH, Wood-Baker R. Supporting health behaviour change in chronic obstructive pulmonary disease with telephone health-mentoring: insights from a qualitative study. BMC Fam Pract. 2012 Jun 13;13:55. doi: 10.1186/1471-2296-13-55.

  PMID: 22694996 BACKGROUND

• Vitacca M, Bianchi L, Guerra A, Fracchia C, Spanevello A, Balbi B, Scalvini S. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. Eur Respir J. 2009 Feb;33(2):411-8. doi: 10.1183/09031936.00005608. Epub 2008 Sep 17.

  PMID: 18799512 BACKGROUND

• Giordano A, Scalvini S, Zanelli E, Corra U, Longobardi GL, Ricci VA, Baiardi P, Glisenti F. Multicenter randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure. Int J Cardiol. 2009 Jan 9;131(2):192-9. doi: 10.1016/j.ijcard.2007.10.027. Epub 2008 Jan 28.

  PMID: 18222552 BACKGROUND

• Paneroni M, Colombo F, Papalia A, Colitta A, Borghi G, Saleri M, Cabiaglia A, Azzalini E, Vitacca M. Is Telerehabilitation a Safe and Viable Option for Patients with COPD? A Feasibility Study. COPD. 2015 Apr;12(2):217-25. doi: 10.3109/15412555.2014.933794. Epub 2014 Aug 5.

  PMID: 25093419 BACKGROUND

• McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD007718. doi: 10.1002/14651858.CD007718.pub2.

  PMID: 21735417 BACKGROUND

• Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Williams JW Jr. Effects of Nurse-Managed Protocols in the Outpatient Management of Adults with Chronic Conditions [Internet]. Washington (DC): Department of Veterans Affairs (US); 2013 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK241377/

  PMID: 25210722 BACKGROUND

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

• Bernocchi P, Scalvini S, Galli T, Paneroni M, Baratti D, Turla O, La Rovere MT, Volterrani M, Vitacca M. A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial. Trials. 2016 Sep 22;17(1):462. doi: 10.1186/s13063-016-1584-x.

  PMID: 27659741 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michele Vitacca, MD

  Fondazione Salvatore Maugeri

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of Respiratory Unit

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: June 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

IT (3)